Rehm K D, Schnelle K, Dyde C J, Blümner E, Arendts W
IPHAR Institut für Klinische Pharmakologie GmbH, München.
Arzneimittelforschung. 1987 Sep;37(9):1058-62.
Sotalol (Sotalex; Sotacor) is a beta-blocker with additional class III antiarrhythmic activity. In this study two intravenous doses of 1.5 mg/kg and 2 mg/kg body weight were administered in 8 healthy volunteers in order to determine the pharmacokinetics and ECG intervals. After a short-term infusion (5 min) plasma levels and the relevant pharmacokinetic parameters were determined. The ECG parameters (QRS, PQ, QT, QTc), blood pressure, heart rate and tolerability were also evaluated. A correlation between the plasma concentration of sotalol, the decrease in heart rate and a prolongation of the real QT interval was found for both dose levels and for a period of 2 h after administration. A prolongation of the QTc-time could only be statistically confirmed for the higher dose. No differences in pharmacokinetic parameters were observed between the two doses.
索他洛尔（苏特来克斯；索他洛尔）是一种兼具Ⅲ类抗心律失常活性的β受体阻滞剂。在本研究中，对8名健康志愿者静脉注射了1.5毫克/千克和2毫克/千克体重这两种剂量，以确定其药代动力学和心电图间期。在短期输注（5分钟）后，测定了血浆水平及相关药代动力学参数。还评估了心电图参数（QRS、PQ、QT、QTc）、血压、心率和耐受性。在给药后2小时内，两种剂量水平下均发现索他洛尔血浆浓度、心率降低与实际QT间期延长之间存在相关性。仅在较高剂量时，QTc时间延长才能得到统计学证实。两种剂量之间未观察到药代动力学参数的差异。
